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  <div class="Regulations Section">
    <h1 class="font-m f36">Section 2 Attachments</h1>
    <p class="f20 font-m">2.1 Regulations</p>
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      <p class="f16 font-r main_text">
        In the fields of pharmaceutical manufacturing and toxicological
        evaluation, regulatory authorities around the world have established a
        series of stringent regulations and standards to ensure the quality and
        safety of drug production as well as consumer health. The AITEP platform
        is dedicated to helping pharmaceutical manufacturers, toxicologists, and
        compliance officers efficiently conduct toxicological evaluations and
        generate toxicology reports that meet international standards.
      </p>
      <br />
      <p class="f16 font-r main_text">
        We provide download links for relevant regulations and guidelines issued
        by major global regulatory authorities. These documents offer essential
        compliance references for users conducting toxicological evaluations.
      </p>
    </div>
    <p class="f16 font-m subheading">
      Download Links for Major Global Pharmaceutical Regulatory Authorities’
      Regulations:
    </p>
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      <p class="f16 font-r main_text">
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<script setup>
const list0 = [
  {
    title01: "PIC/S (Pharmaceutical Inspection Co-operation Scheme)",
    title02: "· Regulation Name: ",
    text: "PIC/S GMP Guide for Medicinal ProductsDownload Link: Click here to downloadIntroduction: PIC/S is a leading global pharmaceutical regulatory cooperation organization, with members including drug regulatory authorities from around the world. The GMP (Good Manufacturing Practices) guide issued by this organization provides detailed requirements for drug production and toxicological evaluation, covering areas such as production quality management, cleaning validation, and toxicological assessment.",
  },
  {
    title01: "EMA (European Medicines Agency)",
    title02: "· Regulation Name: ",
    text: "EMA Guideline on Setting Health-Based Exposure LimitsDownload Link: Click here to downloadIntroduction: The guideline issued by the European Medicines Agency (EMA) specifies standards for setting health-based exposure limits in drug production, including methods for calculating Permitted Daily Exposure (PDE). This guideline is crucial for manufacturers selling drugs in the European market and is an indispensable reference for toxicological evaluations.",
  },
  {
    title01: "FDA (U.S. Food and Drug Administration)",
    title02: "· Regulation Name: ",
    text: "FDA Guidance for Industry on Cleaning ValidationDownload Link: Click here to downloadIntroduction: The guidance document issued by the U.S. Food and Drug Administration (FDA) provides standards and requirements for cleaning validation for pharmaceutical manufacturers selling products in the U.S. market. This guideline covers toxicological evaluation, residue detection, and compliance review processes in cleaning validation.",
  },
  {
    title01:
      "ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)",
    title02: "· Regulation Name: ",
    text: "ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsDownload Link: Click here to downloadIntroduction: The Q7 guideline issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) focuses on standards for the production of active pharmaceutical ingredients, including cleaning validation and toxicological evaluation. This guideline is widely applied in the global pharmaceutical industry.",
  },
  {
    title01: "WHO (World Health Organization)",
    title02: "· Regulation Name: ",
    text: "WHO Guidelines on Good Manufacturing PracticesDownload Link: Click here to downloadIntroduction: The WHO GMP guidelines provide foundational quality management standards for global drug production, with a particular emphasis on cleaning validation, toxicological evaluation, and the management of pharmaceutical production equipment.",
  },
  {
    title01: "ANVISA (Agência Nacional de Vigilância Sanitária - Brazil)",
    title02: "· Regulation Name: ",
    text: "ANVISA Guide on Pharmaceutical Production StandardsDownload Link: Click here to downloadIntroduction: The pharmaceutical production standards guide issued by Brazil's National Health Surveillance Agency (ANVISA) holds significant influence in the South American market, particularly regarding the requirements for cleaning validation and toxicological evaluation.",
  },
  {
    title01: "TGA (Therapeutic Goods Administration - Australia)",
    title02: "· Regulation Name: ",
    text: "TGA Guide to Good Manufacturing PracticesDownload Link: Click here to downloadIntroduction: The GMP guidelines issued by Australia’s Therapeutic Goods Administration (TGA) focus on pharmaceutical manufacturing and cleaning validation, ensuring the safety and compliance of drugs in the Australian market.",
  },
  {
    title01: "CFDA (China Food and Drug Administration)",
    title02: "· Regulation Name: ",
    text: "CFDA Guide to Pharmaceutical Cleaning ValidationDownload Link: Click here to downloadIntroduction: The cleaning validation guide issued by the China Food and Drug Administration (CFDA) provides clear standards for China’s pharmaceutical industry, especially concerning toxicological evaluation in cleaning validation.",
  },
];
</script>
